Current Clean Intermittent Catheters (“CIC”) are single use catheters used for bladder drainage by patients who cannot control either their urinary sphincter muscle or bladder muscles. Conventional CICs are tubular structures having a cylindrical wall with single or multiple openings or drainage eyes in its distal end that communicates with an interior drainage lumen. In use, conventional CICs are inserted into the urethra, through the urinary sphincter (holding it open) and into the bladder for drainage. Once in the bladder, any urine present will drain through the drainage eye, into the internal lumen and through the catheter, into a urine bag or other structure that is connected to the proximal end of the CIC.
One problem seen today with conventional catheters is there is a high Urinary Tract Infection (“UTI”) rate among users who self-catheterize due to bacteria being pushed up from the urethra towards and into the bladder as the catheter is inserted. In normal bladder voiding without a catheter, urine flushes the urethra and any existing bacteria away from the bladder as its flows reducing the chance of UTI, however, because with current CICs, the urine flows through the lumen on the interior of the catheter, flushing of the urethra does not occur.
Another problem experienced with current CICs is that it is very difficult to obtain complete voiding of the bladder. Minimizing residual urine in the bladder depends on accurate positioning of the CIC in the bladder, which is oftentimes difficult to ensure. In particular, the drainage eye of conventional CICs must be accurately positioned with respect to the internal neck of the bladder in order to be relatively certain of removing the maximum amount of urine. Additionally, the soft tissue in the neck area of the bladder sometimes has a tendency to get sucked into the drainage eye, making it difficult to completely drain the bladder.